FDA Rejects Gefapixant NDA for Chronic Cough
The application includes data from the two phase 3 studies, which evaluated the efficacy and safety of gefapixant in adults with refractory or unexplained chronic cough for at least 1 year.
The application includes data from the two phase 3 studies, which evaluated the efficacy and safety of gefapixant in adults with refractory or unexplained chronic cough for at least 1 year.
Some evidence suggests zinc might shorten duration of symptoms, but further research needed to address many unanswered questions
Sixty percent of fatalities occurred in children younger than 2 years of age and 55 percent involved nontherapeutic intent by a caregiver
The most common presenting complaints included shortness of breath, rhinorrhea, and hoarseness.
Since January 1, 2000, there have been 460 documented cases of propylhexedrine abuse or misuse reported to US poison control centers.
The NDA submission is based on data from the double-blind, placebo-controlled phase 3 studies, COUGH-1 and COUGH-2.
Mucinex® Children’s FreeFrom™, a new line of over-the-counter cough and cold products free from artificial flavors, colors, and dyes, has been made available by Reckitt Benckiser.
Genexa has launched 4 over-the-counter (OTC) medicines that contain no artificial ingredients.
The double-blind, placebo-controlled studies, COUGH-1 and COUGH-2, included 730 and 1314 adult patients with refractory or unexplained chronic cough for at least 1 year, respectively.
Betadine Antiseptic Sore Throat Gargle is indicated for adults and children 12 years of age and older.